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Publication numberUS6753017 B2
Publication typeGrant
Application numberUS 09/986,116
Publication dateJun 22, 2004
Filing dateNov 7, 2001
Priority dateNov 7, 2001
Fee statusLapsed
Also published asCN1326517C, CN1582144A, EP1443909A1, US20030086982, US20030104076, WO2003039515A1
Publication number09986116, 986116, US 6753017 B2, US 6753017B2, US-B2-6753017, US6753017 B2, US6753017B2
InventorsWilhelm Berkulin, Karl-Hans Theissing
Original AssigneeJrs Pharma Lp
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Process for preparing dry extracts
US 6753017 B2
Abstract
The process for preparing dry extracts from a liquid extract and at least one additional substance by a spray-drying process is effected by adding said at least one additional substance to the spray-drying process in a dry form during the spray-drying process.
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Claims(9)
What is claimed is:
1. A process for preparing a dry extract composition comprising: combining, in a spray dryer, a liquid extract of a medicinal plant and a dry substance together and spray-drying to produce a spray dried composition consisting essentially of said liquid extract and said dry substance, wherein the dry substance is selected from the group consisting of lactose, maltodextrin, dextrin, dry glucose, starch, microcrystalline cellulose, Povidone, polyethylene glycol, calcium phosphate, magnesium stearate, precipitated silicic acid, precipitated silica, highly dispersed silica, sorbitol, mannitol, and mixtures thereof.
2. The process according to claim 1, wherein the dry substance has a particle size of from 1 to 500 μm.
3. The process of claim 1, wherein the spray dried composition has a residual moisture of less than 5%.
4. The process of claim 1, wherein the liquid extract is introduced into the spray dryer via a nozzle at a pressure of from 10 to 150 bar.
5. The process of claim 1, wherein the spray dryer contains drying air having a temperature between 120 C and 350 C.
6. The process of claim 4, wherein the spray dryer contains drying air having a temperature between 120 C and 350 C.
7. The process of claim 1, wherein the dry substance is introduced into the spray dryer via a blow conveyance.
8. The process of claim 4, wherein the dry substance is introduced into the spray dryer via a blow conveyance.
9. The process of claim 6, wherein the dry substance is introduced into the spray dryer via a blow conveyance.
Description

The present invention relates to a process for preparing dry extracts.

Extracts from plants or plant parts are widely employed in the food and drug fields. In many cases, it is appropriate to dry the thus obtained extracts in order the volume of the extracts. As far as other auxiliary agents are needed for the further processing of the dry extract, these are usually admixed with the liquid extract, followed by commonly drying them. Depending on what use is intended for the thus obtained dry products, further processing steps, such as wet granulation, fluidized-bed drying, compaction etc., can follow.

It has been the object of the present invention to provide a particularly simple process for adding further substances to an extract to be dried.

According to the invention, this object is achieved by a process for preparing dry extracts from a liquid extract and at least one additional substance by a spray-drying process, wherein said at least one additional substance is added to the spray-drying process in a dry form during the spray-drying process.

The wet extract droplets formed by the spraying will mix with said at least one additional substance and are dried on their common way through the spray-dryer, The residual moisture is generally below 5%.

Surprisingly, in this way, a homogeneous free-flowing powder can be obtained, which can be used, for example, directly for tabletting. Such a product is superior to both one obtained by commonly drying a solution of the extract and auxiliary agent, and one obtained by adding the auxiliary agent to the dried extract, with respect to galenic properties, especially tabletting property. Thus, the proportion of auxiliary agent can be significantly reduced as compared to conventional processes, so that smaller tablets can be produced with the same load of active substance, or more active substance can be introduced in predetermined tablet sizes.

The process is particularly useful if the liquid extract is the extract of a medicinal plant whose extract is to be administered in the form of tablets.

Said at least one additional substance will then be a galenic auxiliary agent. Galenic auxiliary agents are known to the skilled person. There may be mentioned, for example, lactose, maltodextrin, dextrin, dry glucose, starch, microcrystalline cellulose, silicated microcrystalline cellulose, Povidone®, polyethylene glycol, calcium phosphate, magnesium stearate, precipitated silicic acid, precipitated silica, highly dispersed silica, sorbitol, mannitol, or mixtures thereof.

The particle size of the additional substance employed is of less importance. Suitable particle sizes are within a range of from 1 to 500 μm.

The process according to the invention results in adhesion of the auxiliary agents to the extracts. Therefore, the invention also relates to the dry extract thus obtained, and to a medicament containing the dry extract according to the invention.

Preferably, the medicament according to the invention is a medicament in a tablet form.

For performing the process, a usual spray-drying plant can be used in which the liquid extract is introduced into a spray tower and drying air is simultaneously fed. By spraying into a hot-air current, the liquid products are quickly and mildly dried within seconds or fractions of seconds. The liquid extract to be dried typically contains from 5 to 70% of dry substance and is introduced into the spray tower at a pressure within a range of from 10 to 150 bar through one or more high-pressure nozzles. Usually, the temperature of the fed-in drying air is between 120 and 350° C., In the process according to the invention, the dry additional substance or a mixture of such substances is also introduced into the spray tower using blow conveyance, preferably in the vicinity of the spraying nozzles for the liquid extract.

For example, the design could be as follows:

A liquid extract is provided in a storage vessel. On a second position, there are dosing scales with the additional substance employed according to the invention in a dry form. The liquid extract is sprayed in together with the finely powdered additional substance at the top of the spray tower through high-pressure nozzles using a pump. Hot air is introduced into the spray tower from below. The exhaust air leaves at the top end of the spray tower and is optionally conducted to a heat exchanger. The dried product is conducted onto a vibrating bed at the lower end of the spray tower and introduced into the further production process. Alternatively, the product may be fed into a cyclone.

EXAMPLES Example 1

146.5 kg of St. John's wort extract having a dry content of 47.8% was spray-dried together with 30.00 kg of silicated microcrystalline cellulose at an air entry temperature of 210° C. and under a nozzle pressure of 40 bar to obtain 93.6 kg of dry product.

Example 2

5236.8 kg of St. John's wort extract having a dry content of 38% was spray-dried together with 104.6 kg of highly dispersed silica at an air entry temperature of 200° C. and under a nozzle pressure of 90 bar to obtain 2065.8 kg of dry product.

Example 3

1819.9 kg of Giant or Late Goldenrod extract having a dry content of 30% was spray-dried together with 221.7 kg of maltodextrin and 23.4 kg of highly dispersed silica at an air entry temperature of 215° C. and under a nozzle pressure of 45 bar to obtain 733.6 kg of dry product.

Example 4

1640.00 kg of valerian root extract having a dry content of 51.8% was spray-dried together with 332.00 kg of dry glucose and 48.6 kg of highly dispersed silica at an air entry temperature of 230° C. and under a nozzle pressure of 80 bar to obtain 1142.8 kg of dry product.

Example 5

658.5 kg of nettle root extract having a dry content of 32% was spray-dried together with 52.7 kg of lactose at an air entry temperature of 220° C. and under a nozzle pressure of 50 bar to obtain 262.4 kg of dry product.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US2756177Mar 9, 1953Jul 24, 1956Hoffmann La RocheProcess for making fat-soluble vitamin active powder
US4395491 *Feb 13, 1981Jul 26, 1983Hoechst AktiengesellschaftMethod for isolating solid matter from a salinomycin culture broth
US4519961 *Aug 30, 1982May 28, 1985Basf AktiengesellschaftProduction of dry powders of substances which are sensitive to oxidation
US4533674Oct 24, 1983Aug 6, 1985Basf Wyandotte CorporationProcess for preparing a sugar and starch free spray-dried vitamin C powder containing 90 percent ascorbic acid
US5466452Feb 28, 1992Nov 14, 1995Phytopharm Ltd.Pharmaceutical compositions for the treatment of skin disorders
US5585115Jan 9, 1995Dec 17, 1996Edward H. Mendell Co., Inc.Pharmaceutical excipient having improved compressability
US5709880Jul 10, 1995Jan 20, 1998Buckman Laboratories International, Inc.Method of making tabletized ionene polymers
US5725883Jun 7, 1995Mar 10, 1998Edward Mendell Co., Inc.Pharmaceutical excipient having improved compressibility
US5725884Sep 30, 1996Mar 10, 1998Edward Mendell Co., Inc.Pharmaceutical excipient having improved compressibility
US5733578Nov 15, 1995Mar 31, 1998Edward Mendell Co., Inc.Directly compressible high load acetaminophen formulations
US5741524Jul 8, 1996Apr 21, 1998Edward Mendell Co., Inc.Sustained-release formulations utilizing pharmaceutical excipient having improved compressibility
US5798101May 1, 1997Aug 25, 1998Hpf, L.L.C.Herbal appetite suppressant and weight loss composition
US5858412Dec 17, 1997Jan 12, 1999Edward Mendell Co., Inc.Sustained release formulations utilizing pharmaceutical excipient having improved compressibility with modified microcrystalline
US5866166Jun 10, 1996Feb 2, 1999Edward Mendell Co., Inc.Pharmaceutical excipient having improved compressibility
US5965166Nov 5, 1997Oct 12, 1999Edward Mendell Co., Inc.Directly compressible high load acetaminophen formulations
US6030645Feb 20, 1998Feb 29, 2000Roche Vitamins Inc.Free-flowing dry particles
US6103219Dec 17, 1997Aug 15, 2000Edward Mendell Co., Inc.Pharmaceutical excipient having improved compressibility
US6106865Mar 10, 1998Aug 22, 2000Edward Mendell Co., Inc.Pharmaceutical excipient having improved compressibility
US6153220Sep 30, 1998Nov 28, 2000Elan Corporation, PlcTaste-masked formulations
US6190696Jun 7, 1999Feb 20, 2001Pieter J. GroenewoudStabilized thyroxine medications
US6217907May 13, 1999Apr 17, 2001Edward Mendell Co., Inc.Directly compressible high load acetaminophen formulations
US6217909Nov 12, 1999Apr 17, 2001Edward Mendell Co., Inc.Pharmaceutical excipient having improved compressibility
US6358533Jan 4, 2001Mar 19, 2002Edward Mendell, Co., Inc.Pharmaceutical excipient having improved compressibility
US6383526Jul 21, 2000May 7, 2002Ancile Pharmaceuticals, Inc.Process for the extraction of valerian root
US6391337Mar 2, 2001May 21, 2002Edward Mendell Co., Inc.Directly compressible high load acetaminophen formulations
US6395303Jun 4, 1997May 28, 2002Edward Mendell Co., Inc.Process for preparing a directly compressible solid dosage form containing microcrystalline cellulose
US6447815 *Dec 19, 2000Sep 10, 2002Access Business Group International LlcHeated alcohol extraction of herbs
US6521261Oct 16, 2001Feb 18, 2003Edward Mendell Co., Inc.Pharmaceutical excipient having improved compressibility
CN1311016AJan 21, 2001Sep 5, 2001程志清Traditional Chinese medicine for curing viral myocarditis and its preparing process
EP0419308A2 *Aug 29, 1990Mar 27, 1991Léon Georges ChevanceUse of glutamic acid or gum arabic as anti-complement agent
GB417552A Title not available
GB1098065A Title not available
WO1999015155A1Sep 18, 1998Apr 1, 1999Leiras OyPharmaceutical preparation comprising clodronate as active ingredient and silicified microcrystalline cellulose as excipient
Non-Patent Citations
Reference
1Database WPI Section Ch, Week 200205, Class B04, AN 2002-034992 ZP002228002 Derwent Publications Lt., London, GB.
2Editor: Budavari S.: "The Merck Index, 12<th >Edition", 1996, XP002227695, p. 1712, paragraph 10159 Merck and Co., Whitehouse Station, NJ., USA.
3Editor: Budavari S.: "The Merck Index, 12th Edition", 1996, XP002227695, p. 1712, paragraph 10159 Merck and Co., Whitehouse Station, NJ., USA.
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US7879382Sep 28, 2006Feb 1, 2011Fmc CorporationStabilizers and compositions and products comprising same
US7998505Aug 16, 2011Fmc CorporationDry granulation binders, products, and use thereof
US8801847Dec 20, 2010Aug 12, 2014Fmc CorporationMicrocrystalline cellulose compositions
US8927609Nov 30, 2012Jan 6, 2015Fmc CorporationCo-attrited stabilizer composition
US8932629Oct 26, 2007Jan 13, 2015Fmc CorporationCo-processed microcrystalline cellulose and sugar alcohol as an excipient for tablet formulations
US9055757Oct 4, 2012Jun 16, 2015Fmc CorporationStabilizer composition of co-attrited microcrystalline cellulose and carboxymethylcellulose, method for making, and uses
US20030206978 *Sep 27, 2002Nov 6, 2003Bob SherwoodAgglomerated particles including an active agent coprocessed with silicified microcrystalline cellulose
US20050196439 *Oct 21, 2004Sep 8, 2005J. Rettenmaier & Soehne Gmbh + Co. KgProcess for co-spray drying agents with dry silicified MCC
US20060115555 *Dec 1, 2004Jun 1, 2006Foulger Sidney WNutritional supplements containing xanthone extracts
US20060115556 *May 12, 2005Jun 1, 2006Foulger Sidney WNutritional supplement drink containing xanthone extracts
US20060228487 *Apr 11, 2005Oct 12, 2006J. Rettenmaier & Söehne GmbH + Co. KGMethods of combining active agents with augmented microcrystalline cellulose
US20070128333 *Sep 28, 2006Jun 7, 2007Tuason Domingo CStabilizers and Compositions and Products Comprising Same
US20080213360 *Oct 26, 2007Sep 4, 2008Fmc CorporationDry granulation binders, products, and use thereof
Classifications
U.S. Classification424/725
International ClassificationA61K47/12, A61K9/20, A61K9/16, A61K47/34, A61K47/32, A61K47/26, A61K47/36, A61K36/00, A61K47/38, A61K47/04
Cooperative ClassificationA61K36/8962, A61K36/77, B01J2/04, A61K36/82, A61K36/28, A61K2236/51
European ClassificationA61K36/82, A61K36/77, A61K36/8962, B01J2/04, A61K36/28
Legal Events
DateCodeEventDescription
May 29, 2003ASAssignment
Owner name: FINZELBERG GMBH & CO. KG, GERMANY
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BERKULIN, WILHELM;THEISSING, KARL-HANS;REEL/FRAME:014116/0880;SIGNING DATES FROM 20030220 TO 20030226
Jun 23, 2003ASAssignment
Owner name: PENWEST PHARMACEUTICALS CO., NEW YORK
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:FINZELBERG GMBH & CO. KG;REEL/FRAME:014195/0695
Effective date: 20030321
Feb 17, 2004ASAssignment
Owner name: J. RETTENMAIER & SOEHNE GMBH + CO. KG, GERMANY
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:PENWEST PHARMACEUTICALS CO.;REEL/FRAME:014978/0898
Effective date: 20040116
Nov 15, 2007FPAYFee payment
Year of fee payment: 4
Dec 22, 2011FPAYFee payment
Year of fee payment: 8
Jan 29, 2016REMIMaintenance fee reminder mailed
Jun 22, 2016LAPSLapse for failure to pay maintenance fees
Aug 9, 2016FPExpired due to failure to pay maintenance fee
Effective date: 20160622